Conditions for new transition periods Medical devices

On 20 March 2023, due to impending supply shortages, the European Commission decided to extend the transitional periods for placing certain medical devices (depending on the class) which are  compliant with the old directive (MDD), on the market, and to no longer restrict the subsequent placing on the market and putting into service. However, these advantages are linked to conditions. For example, it is mandatory that an MDR-compliant submission to a Notified Body has been completed before the MDD certificate expires. The European Commission published a "confirmation letter" template for this on 24 May 2023. In order to be able to submit high-quality technical documentation in accordance with the requirements of MDR 2017/745, the "The European Association of Medical devices Notified Bodies" updated its Best Practice Guidance in April.